# K234118: CentriMag™ Acute Circulatory Support System

- Pathway: 510(k) (Special)
- Applicant: Abbott Medical
- Decided: Jan 26, 2024 after 29 days
- Product code: QNR (Blood Pump For Ecmo, Long-Term (> 6 Hours) Use)
- Device class: 2
- Regulation: 21 CFR 870.4100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K852698 (1985). 22 ancestors in all.
No later device cites it as a predicate yet.
1 of 23 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200306: CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit, Abbott (Formerly Thoratec Corporation) (2020) Summary page 5.
- K222038: CentriMag™ Blood Pump for use with CentriMag™ Acute Circulatory Support System, Abbott (Formerly Thoratec Corporation) (2022) Summary page 5.

## Indications for use
The CentriMag Extracorporeal Blood Pumping System is a non-roller-type cardiopulmonary and circulatory bypass blood pump used to pump a patient's blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either: i. Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels: or ii. Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava The CentriMag™ Blood Pump for use with the CentriMag™ Acute Circulatory Support System (Motor, Monitor, Console, and Flow Probes) is indicated for controlling blood flow as part of an extracorporeal membrane oxygenation (ECMO) circuit. ECMO is intended to provide assisted extracorporeal circulation and physiologic gas exchange of the patients' blood for adult patients with acute respiratory failure and/or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent.

Source page: https://510kreport.com/device/K234118
Methodology: https://510kreport.com/methodology